Initiation of VERSATILE-003 Phase 3 Clinical Trial
PDS Biotech initiated the VERSATILE-003 Phase 3 clinical trial for first line recurrent and/or metastatic HPV16-positive head and neck squamous cell carcinoma. The trial involves approximately 350 patients and aims to demonstrate the efficacy of Versamune HPV + pembrolizumab.
Promising Results from VERSATILE-002 Phase 2 Study
The VERSATILE-002 Phase 2 study showed a median overall survival of 30 months, an objective response rate improvement from 26% to 36%, and a disease control rate improvement from 70% to 77%.
FDA Clearance for MUC1 IND Application
FDA cleared the IND application for the combination of Versamune MUC1 and PDS01ADC to treat metastatic colorectal cancer, representing a significant development for PDS Biotech.
Decreased Net Loss for 2024
Net loss for 2024 was $37.6 million, down from $42.9 million in 2023, primarily due to decreased operating expenses.
Successful Fundraising
PDS Biotech completed an up to $22 million registered direct offering, with $11 million upfront and potential for an additional $11 million from warrant exercises.